Muscles in Liver Diseases (UNIVERSE)
Cirrhosis is the 11th leading cause of death in the world. The progression to cirrhosis occurs as a result of chronic hepatic injury, related to excessive alcohol consumption, non-alcoholic steatohepatitis, chronic viral infection. Cirrhosis is accompanied by symptoms that profoundly affect the quality of life of patients.
Sarcopenia, or decrease in muscle capacity through loss of muscle mass, is associated with liver disease. Patients with liver disease and sarcopenia have increased morbidity, and higher pre- and post-liver transplant mortality than patients without sarcopenia. The mechanism responsible for the development of sarcopenia in liver disease remains largely misunderstood, as do the mechanisms by which sarcopenia appears to promote complications of liver disease.
This study, carried out on a prospective cohort of patients with liver disease, aims at understanding the pathophysiological mechanisms involved in sarcopenia and its consequences.
調査の概要
状態
詳細な説明
Cirrhosis is the 11th leading cause of death in the world. The progression to cirrhosis occurs as a result of chronic hepatic injury, related to excessive alcohol consumption, non-alcoholic steatohepatitis, and chronic viral infection. Cirrhosis is accompanied by symptoms that profoundly affect the quality of life of patients.
Sarcopenia, or decrease in muscle capacity through loss of muscle mass, is associated with liver disease. Patients with liver disease and sarcopenia have increased morbidity, and higher pre- and post-liver transplant mortality than patients without sarcopenia. The mechanism responsible for the development of sarcopenia in liver disease remains largely misunderstood, as do the mechanisms by which sarcopenia appears to promote complications of liver disease.
This study, carried out on a prospective cohort of patients with stable liver disease, aims at understanding the pathophysiological mechanisms involved in sarcopenia and its consequences.
After checking the inclusion criteria, all eligible patients treated at Beaujon Hospital (Clichy) will be invited to participate in the study. After inclusion, clinical and laboratory features (hepatic assessment) will be collected and the blood samples will be taken.
During the surgery, a muscle biopsy will be performed on the incision area. No follow-up is planned.
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：pierre Emmanuel Rautou
- 電話番号：33 140875283
- メール：pierre.emmanuel.rautou@aphp.fr
研究連絡先のバックアップ
- 名前：Enis Kostallari
- 電話番号：33 140875283
- メール：enis.kostallari@gmail.com
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- Patients over the age of 18 having a scheduled abdominal surgery at Beaujon Hospital
- Patient affiliated to a social security scheme
- Informed patient having signed a consent to participate
Exclusion Criteria:
Primary muscle disease (myopathy, dermatopolymyositis, vasculitis with muscle involvement)
- Amyotrophic drugs: long-term corticosteroid therapy
- Immunosuppressive treatments
- Chronic inflammatory disease (example: Crohn's disease)
- Disease known to cause sarcopenia such as -but not limited to- active extrahepatic neoplasia, polycystic hepatorenal disease
- Gastrointestinal haemorrhage in the 15 days prior to inclusion
- Acute alcoholic hepatitis in the month before inclusion
- Infection during treatment
- Pregnant or breastfeeding woman
- Protected populations: people under guardianship or under guardianship
- Patient not affiliated to a social security scheme
- Patient under AME
- Patient not having signed consent
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：基礎科学
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
他の：patients without liver disease,
taking blood samples and biopsy of muscular wall
|
3 citrated tubes and 3 EDTA tubes
a muscle biopsy will be performed on the incision area
|
|
他の：patient with chronic liver disease without cirrhosis,
taking blood samples and biopsy of muscular wall
|
3 citrated tubes and 3 EDTA tubes
a muscle biopsy will be performed on the incision area
|
|
他の：patients with compensated cirrhosis,
taking blood samples and biopsy of muscular wall
|
3 citrated tubes and 3 EDTA tubes
a muscle biopsy will be performed on the incision area
|
|
他の：patient with severe cirrhosis
taking blood samples and biopsy of muscular wall
|
3 citrated tubes and 3 EDTA tubes
a muscle biopsy will be performed on the incision area
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
describe the muscle changes that occur during liver disease.
時間枠：1 month after the of inclusion
|
Assessment of the histology of the muscle removed during abdominal surgery by measuring the diameter of muscle fibers
|
1 month after the of inclusion
|
|
describe the muscle changes that occur during liver disease.
時間枠：1 month after the of inclusion
|
Assessment of the histology of the muscle removed during abdominal surgery, by evaluating the vascularity with measurements of CD31 count and αSMA count
|
1 month after the of inclusion
|
|
describe the muscle changes that occur during liver disease.
時間枠：1 month after the of inclusion
|
Assessment of the histology of the muscle removed during abdominal surgery by evaluating the muscle stem cells with measurements of Pax7, MyoD and Myogenin
|
1 month after the of inclusion
|
|
describe the muscle changes that occur during liver disease.
時間枠：1 month after the of inclusion
|
Assessment of the histology of the muscle removed during abdominal surgery by evaluating gene expression with transcriptomics
|
1 month after the of inclusion
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Identify circulating mediators that could be responsible for sarcopenia: released by the liver and acting on the muscle.
時間枠：1 month after the of inclusion
|
Circulating concentration of mediators / cells suspected of being responsible for sarcopenia:
|
1 month after the of inclusion
|
|
Identify circulating mediators that could be responsible for complications of liver disease: released by the muscle and acting on the different organs
時間枠：1 month after the of inclusion
|
Circulating concentration of mediators / cells suspected of being released by muscle and contributing to organ dysfunction in liver disease:
|
1 month after the of inclusion
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (予想される)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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